MAUDE Adverse Event Report: BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. EUFLEXXA; 1% SODIUM HYALURONATE

Catalog Number 6301182010

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Dyspnea (1816); Pain (1994); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/21/2023

Event Type  Injury  

Event Description

Struggling to catch breath, hard to catch breath [dyspnoea] her chest was tightening up [chest discomfort].She felt just as horrible [feeling abnormal].Case narrative: this is a serious spontaneous case received from a consumer in the united states.This report concerns a 37-year-old female who experienced struggling/hard to catch breath, her chest was tightening up and she felt just as horrible during treatment with euflexxa (sodium hyaluronate) solution 1% for injection, 1 injection in right knee, for an unknown indication from (b)(6) 2023 to an unknown stop date.The patient reported she received her first injection of euflexxa in her right knee yesterday morning ((b)(6) 2023).The patient reported she ended up in the emergency room (er) last night and was struggling to breath, hard to catch her breath, and her chest was tightening up.The patient received benadryl and other intravenous (iv) medications and today ((b)(6) 2023) she felt just as horrible.The patient was sent home with a steroid pack to see if that would help her breathing.The er doctor was going to call her orthopedic doctor to provide an update.The patient did not have the lot number or expiration date to provide.The events struggling to catch breath, hard to catch breath and chest was tightening up, were medically significant.Action taken with euflexxa was unknown.At the time of this report, the outcome of struggling to catch breath, hard to catch breath was unknown, the outcome of her chest was tightening up was unknown, the outcome of she felt just as horrible was not recovered.The following concomitant medications were reported: meloxicam (unknown dates), allegra allergy (unknown dates) and an unspecified birth control implant in arm (unknown dates).The events struggling to catch breath, hard to catch breath and her chest was tightening up were reported as serious.The event she felt just as horrible was reported as non-serious.Sender comment: limited information regarding e.G., medical history, product indication, lab data etc., making difficult to perform a thorough medical evaluation, however, due to a possible temporal relationship, a causal relationship between the reported events and euflexxa cannot be ruled out.Overall listedness (core label) is unlisted.Reporter causality: related company causality: related other case numbers: internal # - others = (b)(4).Internal # - others = (b)(4).This ae occurred in united states and concerns the medical device euflexxa.Please report to your local health authority if required by local law.This ae is not reportable in eu because it does not meet the definition of a medical device incident according to the requirements of the mdd (european council directive of 14 june 1993 93/42/eec concerning medical devices) / mdr (eu) 2017/745 and/or because it did not occur in an eu + efta country + tr and ni and did not result in a corrective action by the manufacturer.No corrective action was done by the manufacturer or requested by regulators.

Event Description

Allergic reaction [hypersensitivity] she felt just as horrible [feeling abnormal] was feeling off [feeling abnormal] allergic reaction [injection site pain] case narrative: this is a serious spontaneous case received from a consumer in the united states.This report concerns a 37-year-old female who experienced struggling/hard to catch breath, her chest was tightening up, she felt just as horrible, injection was painful, throat was scratchy, coughing, red rash all over chest, and allergic reaction during treatment with euflexxa (sodium hyaluronate) solution 1% for injection, 1 injection in right knee, for osteoarthritis from 21-jun-2023 to an unknown stop date.The patient reported she received her first injection of euflexxa in her right knee yesterday morning ( (b)(6) 2023).The patient reported she ended up in the emergency room (er) last night and was struggling to breath, hard to catch her breath, and her chest was tightening up.The patient received benadryl and other intravenous (iv) medications and today ((b)(6) 2023) she felt just as horrible.The patient was sent home with a steroid pack to see if that would help her breathing.The er doctor was going to call her orthopedic doctor to provide an update.The patient did not have the lot number or expiration date to provide.The patient stated that she received the injection at approximately 10 am, it was incredibly painful, and within an hour, was feeling off.The patient did not think anything about it but by 5 pm, she was in the er struggling to breathe.Her throat was scratchy, she began coughing, and had a red rash all over her chest.The patient reported that the doctors immediately began allergic reaction treatments and advised no more euflexxa.Patient was better by the time she was discharged but stated that the next morning ((b)(6) 2023), as she was headed back to the doctor that once again, it was a struggle to breathe.The events struggling to catch breath, hard to catch breath and chest was tightening up, were medically significant.Action taken with euflexxa was unknown.At the time of this report, the outcome of struggling to catch breath, hard to catch breath was not recovered, the outcome of her chest was tightening up injection was painful, feeling abnormal, felt just as horrible was unknown, the outcome of throat was scratchy, coughing, red rash all over chest, allergic reaction was recovering/resolving.The following concomitant medications were reported: meloxicam (unknown dates), allegra allergy (unknown dates) and an unspecified birth control implant in arm (unknown dates).The events struggling to catch breath, hard to catch breath and her chest was tightening up were reported as serious.The events she felt just as horrible, injection was painful, throat was scratchy, coughing, red rash all over chest, allergic reaction were reported as non-serious.At the time of reporting the case outcome was unknown.Sender comment: limited information regarding e.G., medical history, product indication, lab data etc., making difficult to perform a thorough medical evaluation, however, due to a possible temporal relationship, a causal relationship between the reported events and euflexxa cannot be ruled out.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Other case numbers: internal # - others = (b)(4).Internal # - others = (b)(4).E2b company number =(b)(4).Mw 3500a mfr.Rpt.# = 3000164186-2023-00035.Mw 3500a mfr.Rpt.# = 3000164186-2023-00036.Internal # - others = mw5118854.Additional information was received on 10-jul-2023 from consumer via a regulatory authority.Follow up 01: new events of injection was painful, throat was scratchy, coughing, red rash all over chest, allergic reaction were reported.Euflexxa indication was provided.The outcome of struggling to breathe was updated from unknown to not recovered and felt just as horrible updated from not recovered to unknown.Sender comment: limited information regarding e.G., medical history, lab data etc., making difficult to perform a thorough medical evaluation, however, due to a possible temporal relationship, a causal relationship between the reported events and euflexxa cannot be ruled out.This ae occurred in united states and concerns the medical device euflexxa.Please report to your local health authority if required by local law.This ae is not reportable in eu because it does not meet the definition of a medical device incident according to the requirements of the mdd (european council directive of 14 june 1993 93/42/eec concerning medical devices) / mdr (eu) 2017/745 and/or because it did not occur in an eu + efta country + tr and ni and did not result in a corrective action by the manufacturer.No corrective action was done by the manufacturer or requested by regulators.

• Brand Name: EUFLEXXA
• Type of Device: 1% SODIUM HYALURONATE
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.; pob 571, be'er tuvia industria; l zone; kiryat malachi 83104 02; IS 8310402
• MDR Report Key: 17263638
• MDR Text Key: 318545358
• Report Number: 0002244564-2023-00035
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 6301182010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/22/2023
• Event Location: Other
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE),; ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE),; MELOXICAM (MELOXICAM),; MELOXICAM (MELOXICAM),
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 37 YR
• Patient Sex: Female